DOCSLIB.ORG

Symbiotica Specialty Ingredients

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
Symbiotica Specialty Ingredients Symbiotica Speciality Ingredients Sdn. Bhd. Malaysia Symbiotica Speciality Ingredients Sdn. Bhd. Malaysia Established since 2001 Text Manufacturing Facility in Kulim, Kedah First Regionally Owned Manufacturer of APIs in Malaysia and ASEAN Symbiotica Speciality Ingredients Sdn. Bhd. Malaysia Core Activity Research Development & Manufacture of Active Pharmaceutical Ingredients Symbiotica Speciality Ingredients Sdn. Bhd. Accreditation, Certification and Filings Malaysia PIC/S - ICH Q7A GMP CERTIFICATION - NPRA, MALAYSIA US FDA - INSPECTED AND ACCEPTED FACILITY COFEPRIS, MEXICO - GMP CERTIFICATION EDQM CERTIFICATE OF SUITABILITY - 8 PRODUCTS, 2 UNDER EVALUATION US DMF - 8 FILED, 10 MORE BEING FILED REPHINE, UK PHARMASSES GMP MNC - APPROVED SUPPLIERS TO GSK, SANOFI, TAKEDA, MYLAN, STADA, TEVA IS0 9001:2008 CERTIFICATION - BUREAU VERITAS CERTIFICATION The Beginnings Symbiotica Speciality Ingredients Sdn. Bhd. Malaysia - Period of Establishment. 2000 - 01 : - Development. - Commercialisation ( 1 kg Batches ). - Pioneer status. 2002 - 03 : - Scale up ( 5 kgs Batches ). - Expansion & upgrading works ( Grade D Cleanroom of class 100 K ). - GMP certification - ICHQ7A-PIC/S and WHO. 2004 - 06 : - ISO Certification. - First CEP application. - Export Excellence Award ( MITI - MATRADE ). - Enterprise 50 awards - 6th Position ( SME corp - Delloite Malaysia). 2007 - 09 : - First CEP awarded from EDQM - for Dexamethasone Sodium Phosphate. - More CEP applications - for additional produtcs began. - First Major expansion on existing site by addition of adjacent buildings, raising of work space height - Scale up ( 20 kgs batches ). A separate facility for non-steroidal API was set up on the same site. 2010 - 12 : - - Three major MNC supply audits and commercial contracts. - US market developmental efforts - filing of US DMFs. - Awarding of more CEPs. - First US FDA inspection took place by mid 2014 which was successful & entry into the USA market - Cofepris GMP certified. 2013 - 17 : - New site of 15.14 acres was acquired at the nearby Kulim High Tech Park & additional industrial buildings in Taman Industri Waja for the future growth strategy. - Additional CEP filings and DMF compilations made. Symbiotica Symbiotica Today Speciality Ingredients Sdn. Bhd. Malaysia Turnover of USD 17 Million approx. Manufacturing nearly 40 APIs in batch sizes of 1 kg - 100 kgs. 85 % of revenue contributed by exports, one of the largest exporters from the Malaysian Pharmaceutical Industry. Market presence in over 50 countries worldwide : Asia-pacific, Middle east, Russia, Balkans, Africa, Maghreb, Western EU, Eastern EU, North America, Central America, Latin America etc. GMP certified as per the ICH Q7 A guidelines by NPRA, Malaysia, a PIC/S member country, qualified to provide written confirmation as per new EC directive. Successfully inspected and accepted by the US FDA in July 2014. Cofepris GMP certified. Audited regularly by MNCs, EU clients, Independent EU audit agencies & other overseas clients. Hold 8 CEPs & filed 8 US DMFs. Winner of 2 awards – EXPORT EXCELLENCE from MITI & ENTERPRISE 50 from SME Corp. Regular participant in International Pharma fairs. Team of 80 people. Symbiotica Speciality Ingredients Sdn. Bhd. Malaysia Philosophy Believe in Symbiosis, Function with Specialization & Synergy, Deliver Ingredients with Quality, Serve with Excellence, Live with passion ! Make the world Happy, Healthy & lively, as a Life Sciences Company. Symbiotica Speciality Ingredients Sdn. Bhd. Malaysia Core Competence Quality Trust Service Flexibility Reliability Competitiveness Symbiotica Speciality Ingredients Sdn. Bhd. Quality Department Malaysia Regulatory Quality Quality Validation Assurance Control Affairs Symbiotica Speciality Ingredients Sdn. Bhd. Quality Management System Malaysia Pharmaceutical Inspection Cooperation Scheme ( PIC/S ) / ICH Q7A Certified by National Pharmaceutical Regulatory Agency Malaysia ISO 9001: 2008 Certified by Bureau Veritas Quality International QMS managed and implemented through a 5 Step Plan International Certification Client Audits/ Local Regulatory Internal Audit Regulatory Audit Vendor Audits Audits Audit Symbiotica Quality Assurance Speciality Ingredients Sdn. Bhd. Malaysia Responsible for Quality Management system and batch release Ensures Compliance towards ICH Q7A GMP & ISO 9001:2008 Conducts Training & retraining to ensure that personnel follow SoPs Efects Surveillance audits to enforce QMS & GMP Carries out Annual Internal Audits & Management Review Documentation preparation, implementation, review and control. Designs & implements procedures related to validation involving process, cleaning procedures, equipment qualification, utility qualification. Regulatory document management in terms of preparation, submission, registration, review of Drug Master Files as well as responding to regulatory queries from regulatory authorities and customers. Approval, filing and review of change controls, deviations, CAPAs, etc. Management of Annual Product Review, Customer Complaints & Investigation when necessary. Issuance & Review of Batch Manufacturing Records. Preparation and maintenance of Master Protocol such as SoP list & Validation Protocol Management of Vendor Qualification. Symbiotica Filing of Speciality Ingredients Sdn. Bhd. Regulatory Drug Master files Malaysia Common Technical Documents Affairs Technical Packs RA US DMFs CEP/COS RA RA BETAMETHASONE VALERATE BETAMETHASONE VALERATE BETAMETHASONE DIPROPIONATE BETAMETHASONE DIPROPIONATE CLOBETASOL PROPIONATE BETAMETHASONE SODIUM PHOSPHATE DEXAMETHASONE SODIUM PHOSPHATE Registration with CLOBETASOL PROPIONATE HALOBETASOL PROPIONATE authorities, DEXAMETHASONE SODIUM PHOSPHATE HYDROCORTISONE VALERATE Answering of MOMETASONE FUROATE MOMETASONE FUROATE queries of PREDNISOLONE ACETATE EXEMESTANE authorities & TIBOLONE customers APPLIED : EXEMESTANE TESTOSTERONE PROPIONATE Symbiotica Manufacturing Site - Current Speciality Ingredients Sdn. Bhd. Malaysia Steroidal Block 10 Mts/Annum Multiproduct Site Non-Steroidal Block Kulim, Kedah, Malaysia 20 Mts/Annum Symbiotica Speciality Ingredients Sdn. Bhd. Manufacturing activity Malaysia Facility is spread over 27,000 sqft (2,500 m2 ) land area with 2 separate manufacturing blocks for Steroidal and Non-Steroidal APIs. Centralized warehouse is located inside a separate building. Raw materials are subjected to quarantine, sampling & QC release prior to dispensing in separate and dedicated Down-Flow Booths prior to transfer for production. Production involves various chemical synthetic steps involving reaction, distillation, extraction, separation etc., which are carried out in the Crude Chemical area. This area is equipped with Reactions Vessels made of Stainless Steel, Mild-Steel-Glass-Lined, Full-Glass, etc. Condensers, Centrifuges, Neutsche Filters, Sparkler Filter, Tray Dryers, etc. Final Powder Processing is carried out in a ISO Class 8 Clean-Room involving Drying, Milling, Micronization, Blending, Packing etc. Equipments used in this area are Tray Dryers, Vacuum Tray Dryers, Rotary Cone Vacuum Dryers, Blenders, Mills and Micronizers. Packing is carried out only after final QA batch release. In-Process Quality Control ensures adherence to standard procedures for consistent Quality under GMP compliance Plant utilities involve Huber Temperature Control Systems, Chillers, Nitrogen Generator, Vacuum Pumps, DI water system, Scrubber, Evaporative Ventilation Systems, Exhausts, Air-Handling Units etc. Symbiotica Speciality Ingredients Sdn. Bhd. Facility Layout Malaysia 519 518 517 Non-Steroidal Chemical Area Steroidal Chemical Area Centralized Warehouse Non-Steroidal Common Powder Zone Steroidal Powder Processing Area Processing QC-Int QC-W Symbiotica Manufacturing Sites Speciality Ingredients Sdn. Bhd. Malaysia Site I : Current Address 518, Jalan Waja 4, Taman Industri Waja, 09000, Kulim, Kedah Size 27,000 sft Certifications NPRA - ICH Q7A : PIC/S GMP certification ( Last inspection - Sep’15 ) US FDA - successfully inspected and accepted ( Last inspection - July’14 ) Site II : New - Green Field Address Lot 4, Industrial Zone Phase 2, Kulim Hi-tech Park, 09000, Kulim, Kedah Size 15.14 acres ( 659,498.4 sft ) Certifications - - Symbiotica Location of the the Sites Speciality Ingredients Sdn. Bhd. Malaysia Current Site New Site Symbiotica Speciality Ingredients Sdn. Bhd. Malaysia Symbiotica - II Kulim Hitech industrial estate Targeted date of completion : End 2018 15.14 Acres / 612700 sqm / 659499 sqft Symbiotica Speciality Ingredients Sdn. Bhd. Proposed Activities at the New Green Field Site Malaysia Sterile Steroidal API - Crystallized / Lyophilized Non-steroidal API Block Additional Steroidal & Hormonal API Blocks Steroid Intermediate Blocks Fermentation Block Phytochemical R&D and Industrial facility Symbiotica Speciality Ingredients Sdn. Bhd. Our Values Malaysia Associate with a spirit of Symbiosis towards mutually beneficial co-existence in all Symbiosis spheres - Internally & Externally Customized solutions in terms of tailoring quality, packaging, sterilization, analysis etc to suit customer needs. Impurity profile, Particle size distribution etc are = Customization customizable. Very high level of reliability achieved through Prompt responsiveness, Maintenance of Reliability ample inventory levels, Secure QMS, Timely deliveries etc. Responsible approach towards servicing of client’s regulatory needs, effective & empathetic handling of customer feedbacks, successfully undergoing audits with an open & transparent attitude, etc have contributed
Load more

Recommended publications
  • Zhejiang Xianju Pharmaceutical Co. Ltd
    No.1, Xianyao Road, Xianju, Zhejiang, China, 317300 Xianju Pharma Outline Outline I. Brief Introduction II. Quality Unit III. Production System IV. EHS System I. Brief Introduction Xianju Pharma Zhejiang Xianju Pharmaceutical Co., Ltd. A professional manufacturer of steroids and hormone products with largest scale and maximum varieties in China. A state-designated manufacturer of contraceptive drugs in China. Company Milestones Jan 1972 Foundation of company May 1997 Incorporated into Zhejiang Medicine Co., Ltd Oct. 1999 Listed in Shanghai Stock Market Jun. 2000 Reorganized into Xianju Pharmaceutical Co., Ltd Dec. 2001 Reformed to Zhejiang Xianju Pharmaceutical Co., Ltd Jan. 2010 listed in Shenzhen Stock Market Location of Xianju There are six airports around Shanghai Xianju, which makes us easily accessible for our partners. Headquarter Hangzhou Located in Xianju, Taizhou City Ningbo Yangfu Site (FPPs) Located in Yangfu, Xianju, Taizhou Yiwu City 6.8km from headquarter Duqiao Site (APIs) Located in LinHai, TaiZhou City, 82.9km from headquarter Taizhou Wenzhou Yangfu Site (APIs) Under construction, finish at 2017 Company Organization General Manager Vice G.M for Vice G.M Vice G.M for Vice G.M for Vice G.M for Quality Director Sales for Market Administration Finance Technology Finance Dept Finance Dept Application Tech Dept Endineering Construction Domestic DrugRegistrationDept. Research& Development Dept. Marketing Dept. Marketing Quality Control Quality Domestic Trading Dept International TradeDep Quality Assurance For FPP Quality Assurance For API Regulatory AffairsDept Human Resource Dept Information Technology Dept Dept Enterprise Management Dept Affairs Administrative Taizhou Xianju Quality System Quality Xianju Taizhou . t G.M. Assistant EHS Dept Production Management Dept G.M.
    [Show full text]
  • This Fact Sheet Provides Information to Patients with Eczema and Their Carers. About Topical Corticosteroids How to Apply Topic
    This fact sheet provides information to patients with eczema and their carers. About topical corticosteroids You or your child’s doctor has prescribed a topical corticosteroid for the treatment of eczema. For treating eczema, corticosteroids are usually prepared in a cream or ointment and are applied topically (directly onto the skin). Topical corticosteroids work by reducing inflammation and helping to control an over-reactive response of the immune system at the site of eczema. They also tighten blood vessels, making less blood flow to the surface of the skin. Together, these effects help to manage the symptoms of eczema. There is a range of steroids that can be used to treat eczema, each with different strengths (potencies). On the next page, the potencies of some common steroids are shown, as well as the concentration that they are usually used in cream or ointment preparations. Using a moisturiser along with a steroid cream does not reduce the effect of the steroid. There are many misconceptions about the side effects of topical corticosteroids. However these treatments are very safe and patients are encouraged to follow the treatment regimen as advised by their doctor. How to apply topical corticosteroids How often should I apply? How much should I apply? Apply 1–2 times each day to the affected area Enough cream should be used so that the of skin according to your doctor’s instructions. entire affected area is covered. The cream can then be rubbed or massaged into the Once the steroid cream has been applied, inflamed skin. moisturisers can be used straight away if needed.
    [Show full text]
  • California Proposition 65 Toxicity List
    STATE OF CALIFORNIA ENVIRONMENTAL PROTECTION AGENCY OFFICE OF ENVIRONMENTAL HEALTH HAZARD ASSESSMENT SAFE DRINKING WATER AND TOXIC ENFORCEMENT ACT OF 1986 CHEMICALS KNOWN TO THE STATE TO CAUSE CANCER OR REPRODUCTIVE TOXICITY 4-Mar-05 The Safe Drinking Water and Toxic Enforcement Act of 1986 requires that the Governor revise and Chemical Type of Toxicity CAS No. Date Listed A-alpha-C (2-Amino-9H-pyrido[2,3-b]indole) cancer 26148685 1-Jan-90 Acetaldehyde cancer 75070 1-Apr-88 Acetamide cancer 60355 1-Jan-90 Acetazolamide developmental 59665 20-Aug-99 Acetochlor cancer 34256821 1-Jan-89 Acetohydroxamic acid developmental 546883 1-Apr-90 2-Acetylaminofluorene cancer 53963 1-Jul-87 Acifluorfen cancer 62476599 1-Jan-90 Acrylamide cancer 79061 1-Jan-90 Acrylonitrile cancer 107131 1-Jul-87 Actinomycin D cancer 50760 1-Oct-89 Actinomycin D developmental 50760 1-Oct-92 Adriamycin (Doxorubicin hydrochloride) cancer 23214928 1-Jul-87 AF-2;[2-(2-furyl)-3-(5-nitro-2-furyl)]acrylamide cancer 3688537 1-Jul-87 Aflatoxins cancer --- 1-Jan-88 Alachlor cancer 15972608 1-Jan-89 Alcoholic beverages, when associated with alcohol abuse cancer --- 1-Jul-88 Aldrin cancer 309002 1-Jul-88 All-trans retinoic acid developmental 302794 1-Jan-89 Allyl chloride Delisted October 29, 1999 cancer 107051 1-Jan-90 Alprazolam developmental 28981977 1-Jul-90 Altretamine developmental, male 645056 20-Aug-99 Amantadine hydrochloride developmental 665667 27-Feb-01 Amikacin sulfate developmental 39831555 1-Jul-90 2-Aminoanthraquinone cancer 117793 1-Oct-89 p -Aminoazobenzene cancer
    [Show full text]
  • Betamethasone Valerate Foam: a Look at the Clinical Data
    Review: Clinical Trial Outcomes Betamethasone valerate foam: a look at the clinical data Clin. Invest. (2014) 4(3), 259–267 Topical corticosteroids and especially betamethasone valerate (BMV) have Avner Shemer1, Nicole Sakka1 & been used topically to relieve many inflammatory skin conditions such as Dov Tamarkin*2 psoriasis and atopic dermatitis. The vehicle used to deliver topical drugs 1Department of Dermatology, the Chaim Sheba Medical Center, Affiliated with the can influence the performance of these topical applications. BMV has Tel-Aviv University, Sackler School of Medicine, traditionally been available in creams, ointments, lotions and sprays. In Tel Hashomer, Israel the early 2000s, a topical hydroethanolic BMV foam became commercially 2Foamix Ltd., 2 Holzman Street, Weizmann available. Subsequently, alcohol-free emulsion- and petrolatum-based Science Park, Rehovot 76704, Israel foam formulations were also developed. This manuscript reviews the *Author for correspondence: Tel.: +972 52 457 5677 properties of BMV foams and clinical studies that have been conducted Fax: +972 8 853 1102 to assess their efficacy and safety as treatments for scalp and non-scalp [email protected] psoriasis, as well as other dermatological inflammatory conditions. Keywords: betamethasone valerate • foam • psoriasis • topical corticosteroids Topical corticosteroids have been ranked in four groups consisting of seven classes ranging from ultra-high potency preparations (class 1) to low-potency prepara- tions (class 7). Betamethasone valerate (BMV) is a mid-potency corticosteroid (class 3–5, depending on the dosage form), used topically to relieve inflammatory skin conditions. It is used as a treatment for psoriasis, atopic dermatitis and other corticosteroid-responsive dermatoses. The vehicle used to deliver topical drugs can influence the performance of these drugs.
    [Show full text]
  • COMBINED LIST of Particularly Hazardous Substances
    COMBINED LIST of Particularly Hazardous Substances revised 2/4/2021 IARC list 1 are Carcinogenic to humans list compiled by Hector Acuna, UCSB IARC list Group 2A Probably carcinogenic to humans IARC list Group 2B Possibly carcinogenic to humans If any of the chemicals listed below are used in your research then complete a Standard Operating Procedure (SOP) for the product as described in the Chemical Hygiene Plan. Prop 65 known to cause cancer or reproductive toxicity Material(s) not on the list does not preclude one from completing an SOP. Other extremely toxic chemicals KNOWN Carcinogens from National Toxicology Program (NTP) or other high hazards will require the development of an SOP. Red= added in 2020 or status change Reasonably Anticipated NTP EPA Haz list COMBINED LIST of Particularly Hazardous Substances CAS Source from where the material is listed. 6,9-Methano-2,4,3-benzodioxathiepin, 6,7,8,9,10,10- hexachloro-1,5,5a,6,9,9a-hexahydro-, 3-oxide Acutely Toxic Methanimidamide, N,N-dimethyl-N'-[2-methyl-4-[[(methylamino)carbonyl]oxy]phenyl]- Acutely Toxic 1-(2-Chloroethyl)-3-(4-methylcyclohexyl)-1-nitrosourea (Methyl-CCNU) Prop 65 KNOWN Carcinogens NTP 1-(2-Chloroethyl)-3-cyclohexyl-1-nitrosourea (CCNU) IARC list Group 2A Reasonably Anticipated NTP 1-(2-Chloroethyl)-3-cyclohexyl-1-nitrosourea (CCNU) (Lomustine) Prop 65 1-(o-Chlorophenyl)thiourea Acutely Toxic 1,1,1,2-Tetrachloroethane IARC list Group 2B 1,1,2,2-Tetrachloroethane Prop 65 IARC list Group 2B 1,1-Dichloro-2,2-bis(p -chloropheny)ethylene (DDE) Prop 65 1,1-Dichloroethane
    [Show full text]
  • 4. Antibacterial/Steroid Combination Therapy in Infected Eczema
    Acta Derm Venereol 2008; Suppl 216: 28–34 4. Antibacterial/steroid combination therapy in infected eczema Anthony C. CHU Infection with Staphylococcus aureus is common in all present, the use of anti-staphylococcal agents with top- forms of eczema. Production of superantigens by S. aureus ical corticosteroids has been shown to produce greater increases skin inflammation in eczema; antibacterial clinical improvement than topical corticosteroids alone treatment is thus pivotal. Poor patient compliance is a (6, 7). These findings are in keeping with the demon- major cause of treatment failure; combination prepara- stration that S. aureus can be isolated from more than tions that contain an antibacterial and a topical steroid 90% of atopic eczema skin lesions (8); in one study, it and that work quickly can improve compliance and thus was isolated from 100% of lesional skin and 79% of treatment outcome. Fusidic acid has advantages over normal skin in patients with atopic eczema (9). other available topical antibacterial agents – neomycin, We observed similar rates of infection in a prospective gentamicin, clioquinol, chlortetracycline, and the anti- audit at the Hammersmith Hospital, in which all new fungal agent miconazole. The clinical efficacy, antibac- patients referred with atopic eczema were evaluated. In terial activity and cosmetic acceptability of fusidic acid/ a 2-month period, 30 patients were referred (22 children corticosteroid combinations are similar to or better than and 8 adults). The reason given by the primary health those of comparator combinations. Fusidic acid/steroid physician for referral in 29 was failure to respond to combinations work quickly with observable improvement prescribed treatment, and one patient was referred be- within the first week.
    [Show full text]
  • Bluecross Blueshield of Western New York Formulary 1 Please Bring This Guide with You the Next Time You Visit Your Doctor
    BlueCross BlueShield of Western New York Formulary 1 Please bring this guide with you the next time you visit your doctor. If you have questions about your prescription drug benefit, visit the Pharmacy Services section of the BlueCross BlueShield web site at www.bcbswny.com. CRP2107_009678.1 MG009678A (Revise Date 07/01/2021) A Division of HealthNow New York Inc. An independent licensee of the BlueCross BlueShield Association. The Cross and Shield are registered trademarks of the BlueCross BlueShield Association. Inside front cover TABLE OF CONTENTS INTRODUCTION . iii UNDERSTANDING THE SYMBOLS USED THROUGHOUT THIS BOOK . iii USING THIS FORMULARY BOOK TO HELP CONTAIN COSTS . iv Save Money on Your Prescription Drugs . iv Finding Medications in the Guide . v SECTION 1 — THERAPEUTIC DRUG CATEGORIES . 1 SECTION II — INDEX . 8 ii The BlueCross BlueShield of Western New York Formulary 1 is a list of drugs to help guide physicians and pharmacists to select the medication that provides the appropriate treatment for the best price. INTRODUCTION BlueCross Blue Shield of Western New York has established an independent committee of practicing physicians and a pharmacist to help ensure that our formularies are medically sound and that they support your patients’ health. This committee—called the Pharmacy and Therapeutics Committee—reviews and evaluates medications on the formulary based on safety and efficacy to help maintain clinical integrity in all therapeutic categories. UNDERSTANDING THE SYMBOLS USED THROUGHOUT THIS BOOK Throughout this book, you will see certain symbols that indicate a management program is in place for selected medications. The symbols are as follows: Key P = A step edit applies to this drug.
    [Show full text]
  • Updates in Pediatric Dermatology
    Peds Derm Updates ELIZABETH ( LISA) SWANSON , M D ADVANCED DERMATOLOGY COLORADO ROCKY MOUNTAIN HOSPITAL FOR CHILDREN [email protected] Disclosures Speaker Sanofi Regeneron Amgen Almirall Pfizer Advisory Board Janssen Powerpoints are the peacocks of the business world; all show, no meat. — Dwight Schrute, The Office What’s New In Atopic Dermatitis? Impact of Atopic Dermatitis Eczema causes stress, sleeplessness, discomfort and worry for the entire family Treating one patient with eczema is an example of “trickle down” healthcare Patients with eczema have increased risk of: ADHD Anxiety and Depression Suicidal Ideation Parental depression Osteoporosis and osteopenia (due to steroids, decreased exercise, and chronic inflammation) Impact of Atopic Dermatitis Sleep disturbances are a really big deal Parents of kids with atopic dermatitis lose an average of 1-1.5 hours of sleep a night Even when they sleep, kids with atopic dermatitis don’t get good sleep Don’t enter REM as much or as long Growth hormone is secreted in REM (JAAD Feb 2018) Atopic Dermatitis and Food Allergies Growing evidence that food allergies might actually be caused by atopic dermatitis Impaired barrier allows food proteins to abnormally enter the body and stimulate allergy Avoiding foods can be harmful Proper nutrition is important Avoidance now linked to increased risk for allergy and anaphylaxis Refer severe eczema patients to Allergist before 4-6 mos of age to talk about food introduction Pathogenesis of Atopic Dermatitis Skin barrier
    [Show full text]
  • Superior Nuclear Receptor Selectivity and Therapeutic Index of Methylprednisolone Aceponate Versus Mometasone Furoate
    DOI:10.1111/j.1600-0625.2007.00597.x www.blackwellpublishing.com/EXD Original Article Superior nuclear receptor selectivity and therapeutic index of methylprednisolone aceponate versus mometasone furoate Parham Mirshahpanah1, Wolf-Dietrich Do¨ cke2, Udo Merbold2, Khusru Asadullah2, Lars Ro¨se2, Heike Scha¨ cke2 and Thomas M. Zollner1 1Research Business Area Dermatology, Berlex Biosciences, Richmond, CA, USA; 2Corporate Research Area Inflammation, Bayer Schering Pharma, Berlin, Germany Correspondence: Thomas M. Zollner, TRG Inflammation, Bayer Schering Pharma, Berlin, Germany, Tel.: +1 510 669 4272, e-mail: [email protected] Accepted for publication 18 June 2007 Abstract: Although introduced more than 50 years ago, topical a relevant rodent model in vivo. We demonstrate that glucocorticoids are still the first line therapy for many methylprednisolone aceponate displays higher specificity in inflammatory skin disorders such as atopic eczema, contact nuclear receptor binding compared with mometasone furoate. dermatitis and many others. Recently, significant improvements Methylprednisolone aceponate was also markedly superior in have been made to optimize the ratio of desired to unwanted terms of minimizing induction of skin atrophy or telangiectasias effects. While with early compounds such as triamcinolone, when compared with mometasone furoate. Based on these topical side effects such as skin atrophy and telangiectasias can be observations, methylprednisolone aceponate is expected to have a observed rather frequently, newer drugs such as methyl- greater therapeutic index as compared with mometasone furoate, prednisolone aceponate or mometasone furoate have a at least in the test systems used here. The degree to which this significantly improved therapeutic index. The present study observation may translate into a clinical setting requires compared these two modern topical glucocorticoids, which confirmation.
    [Show full text]
  • Pharmacy and Poisons (Third and Fourth Schedule Amendment) Order 2017
    Q UO N T FA R U T A F E BERMUDA PHARMACY AND POISONS (THIRD AND FOURTH SCHEDULE AMENDMENT) ORDER 2017 BR 111 / 2017 The Minister responsible for health, in exercise of the power conferred by section 48A(1) of the Pharmacy and Poisons Act 1979, makes the following Order: Citation 1 This Order may be cited as the Pharmacy and Poisons (Third and Fourth Schedule Amendment) Order 2017. Repeals and replaces the Third and Fourth Schedule of the Pharmacy and Poisons Act 1979 2 The Third and Fourth Schedules to the Pharmacy and Poisons Act 1979 are repealed and replaced with— “THIRD SCHEDULE (Sections 25(6); 27(1))) DRUGS OBTAINABLE ONLY ON PRESCRIPTION EXCEPT WHERE SPECIFIED IN THE FOURTH SCHEDULE (PART I AND PART II) Note: The following annotations used in this Schedule have the following meanings: md (maximum dose) i.e. the maximum quantity of the substance contained in the amount of a medicinal product which is recommended to be taken or administered at any one time. 1 PHARMACY AND POISONS (THIRD AND FOURTH SCHEDULE AMENDMENT) ORDER 2017 mdd (maximum daily dose) i.e. the maximum quantity of the substance that is contained in the amount of a medicinal product which is recommended to be taken or administered in any period of 24 hours. mg milligram ms (maximum strength) i.e. either or, if so specified, both of the following: (a) the maximum quantity of the substance by weight or volume that is contained in the dosage unit of a medicinal product; or (b) the maximum percentage of the substance contained in a medicinal product calculated in terms of w/w, w/v, v/w, or v/v, as appropriate.
    [Show full text]
  • Mometasone Powder Rationale for Inclusion In
    MOMETASONE POWDER RATIONALE FOR INCLUSION IN PA PROGRAM Background Mometasone is a corticosteroid demonstrating potent anti-inflammatory activity able to decrease inflammation through a mechanism of action that is not known. However, corticosteroids are thought to act by the induction of phospholipase A2, which leads to the inhibition of a common precursor for potent inflammatory mediators. Topical corticosteroids can be absorbed from normal intact skin. Inflammation and/or other disease processes in the skin increase percutaneous absorption (1). Mometasone is commercially available in the following dosage forms: topical cream, topical lotion, topical ointment, nasal spray and as a powder for inhalation. Regulatory Status FDA approved topical indication: Mometasone is a corticosteroid indicated for the relief of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 2 years of age and older (1). The safety and efficacy of mometasone have not been established in pediatric patients below 2 years of age (1). Summary Topical steroids have anti-inflammatory, antipruritic, and vasoconstrictive properties. Mometasone is FDA-approved for inflammatory and pruritic manifestations of corticosteroid- responsive dermatoses in patients 2 years of age and older. The safety and efficacy of mometasone have not been established in pediatric patients below 2 years of age (1). Mometasone is commercially available in the following dosage forms: topical cream, topical lotion, topical ointment, nasal spray and as powder for inhalation. Mometasone powder may be considered medically necessary in a topical formulation for patients 2 years of age or older for the treatment of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Mometasone powder may be considered investigational in a topical formulation for patients Mometasone Powder FEP Clinical Rationale MOMETASONE POWDER under the age of 2 years, or in patients without a diagnosis of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
    [Show full text]
  • Steroid Use in Prednisone Allergy Abby Shuck, Pharmd Candidate
    Steroid Use in Prednisone Allergy Abby Shuck, PharmD candidate 2015 University of Findlay If a patient has an allergy to prednisone and methylprednisolone, what (if any) other corticosteroid can the patient use to avoid an allergic reaction? Corticosteroids very rarely cause allergic reactions in patients that receive them. Since corticosteroids are typically used to treat severe allergic reactions and anaphylaxis, it seems unlikely that these drugs could actually induce an allergic reaction of their own. However, between 0.5-5% of people have reported any sort of reaction to a corticosteroid that they have received.1 Corticosteroids can cause anything from minor skin irritations to full blown anaphylactic shock. Worsening of allergic symptoms during corticosteroid treatment may not always mean that the patient has failed treatment, although it may appear to be so.2,3 There are essentially four classes of corticosteroids: Class A, hydrocortisone-type, Class B, triamcinolone acetonide type, Class C, betamethasone type, and Class D, hydrocortisone-17-butyrate and clobetasone-17-butyrate type. Major* corticosteroids in Class A include cortisone, hydrocortisone, methylprednisolone, prednisolone, and prednisone. Major* corticosteroids in Class B include budesonide, fluocinolone, and triamcinolone. Major* corticosteroids in Class C include beclomethasone and dexamethasone. Finally, major* corticosteroids in Class D include betamethasone, fluticasone, and mometasone.4,5 Class D was later subdivided into Class D1 and D2 depending on the presence or 5,6 absence of a C16 methyl substitution and/or halogenation on C9 of the steroid B-ring. It is often hard to determine what exactly a patient is allergic to if they experience a reaction to a corticosteroid.
    [Show full text]